This randomized phase III trial studies diet and physical activity changes to see how well they work compared with usual care in improving progression-free survival in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy lifestyle and counseling after treatment may improve progression-free survival in patients with previously treated cancer.

Progression-free survival [ Time Frame: From entry onto the protocol to the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause, up to 9 years ] [ Designated as safety issue: No ]

Will be assessed by a log-rank test stratified by stage of disease (II and III vs. IV) and consolidation therapy (yes or no).

Secondary Outcome Measures:

Change in self-reported quality of life measured using RAND-36 [ Time Frame: Baseline to up to 24 months ] [ Designated as safety issue: No ]

Pain measured using RAND-36 and GSRS-IBS [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Will be examined in exploratory manner and summarized with descriptive statistics such as the mean score accompanied with standardized deviation for each group at each assessment time points. No hypotheses testing will be conducted.

Role limitations due to physical health and emotional problems measured using RAND-36 and GSRS-IBS [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Will be examined in exploratory manner and summarized with descriptive statistics such as the mean score accompanied with standardized deviation for each group at each assessment time points. No hypotheses testing will be conducted.

Mental health measured using RAND-36 and GSRS-IBS [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Will be examined in exploratory manner and summarized with descriptive statistics such as the mean score accompanied with standardized deviation for each group at each assessment time points. No hypotheses testing will be conducted.

Vitality measured using RAND-36 and GSRS-IBS [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Will be examined in exploratory manner and summarized with descriptive statistics such as the mean score accompanied with standardized deviation for each group at each assessment time points. No hypotheses testing will be conducted.

Social functioning measured using RAND-36 and GSRS-IBS [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Will be examined in exploratory manner and summarized with descriptive statistics such as the mean score accompanied with standardized deviation for each group at each assessment time points. No hypotheses testing will be conducted.

Total carotenoid level [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Will be used to estimate compliance to the dietary portion of the healthy lifestyle intervention.

Treatment compliance [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]

Participants receive a dietary intervention designed to promote increased levels of plasma carotenoids, control weight, and to ensure adequacy of micronutrient intake. Participants also undergo a physical activity intervention comprising a moderately low aerobic regimen to raise the usual activity level. Participants also undergo face-to-face counseling, receive educational materials and counseling focused on how to read food labels to estimate grams of fat per serving and serving size, and undergo telephone counseling by a lifestyle intervention counselor once a week for 4 weeks, then twice a month for 6 months, monthly for the subsequent 6 months, and then once every other month for 11 months. Participants complete daily fat gram and step diaries at least three times per week.

Behavioral: behavioral dietary intervention

Receive dietary intervention

Behavioral: exercise intervention

Undergo physical activity intervention

Other: counseling intervention

Undergo face-to-face and telephone counseling

Other Name: counseling and communications studies

Other: educational intervention

Receive educational materials

Other Name: intervention, educational

Behavioral: compliance monitoring

Complete daily fat gram and step diaries

Other: questionnaire administration

Ancillary studies

Other: quality-of-life assessment

Ancillary studies

Other Name: quality of life assessment

Other: laboratory biomarker analysis

Correlative studies

Active Comparator: Group II (observation)

Participants receive a study notebook containing general study-related information. Participants are not asked to record diet or physical activity but are provided a single sample diary in their study notebook. Participants receive telephone contact on a sliding scale similar to the intervention group, but at less frequent intervals (22 versus 33 calls over the course of the intervention).

Patients must have completed all primary chemotherapy and consolidation therapy (if administered) at least 6 weeks, and no more than 6 months and 2 weeks, prior to enrollment and must be in complete remission; consolidation therapy is defined as any chemotherapy or biological therapy used for a patient who has completed at least four courses of primary chemotherapy and had documented complete remission prior to initiation of such chemotherapy or biological therapy

Patients must have achieved a documented complete response to treatment based on normal cancer antigen (CA)-125 and computed tomography (CT) scan or magnetic resonance imaging (MRI) with contrast (i.e. there must be no clinical evidence of persistent or recurrent disease based on CA-125 and CT scan or MRI with contrast)

Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2

Patients must not be currently enrolled in an ongoing (participating for 6 months or longer) medically prescribed diet or physical activity regimen

Patients must have signed an approved informed consent and authorization permitting release of personal health information

Patients must be willing to provide name and appropriate telephone contact information and be willing to be contacted periodically via telephone by The University of Arizona Cancer Center (AZCC) staff for completion of individualized lifestyle intervention coaching, completion of the Pittsburgh Sleep Quality Index, and for clarification of patient-completed responses if necessary; patient must be willing to have Arizona Food Frequency Questionnaire (AFFQ), Arizona Physical Activity Questionnaire (APAQ), baseline questionnaire, and personal contact information sent to AZCC

Exclusion Criteria:

Patients with GOG performance grade of 3 or 4

Patients may not have a history of other invasive malignancies within the last five years, with the exception of non-melanoma skin cancer or stage 1A endometrioid adenocarcinoma of the uterus

Patients who are currently undergoing treatment (primary or consolidation) for stage II, III or IV ovarian, fallopian tube or primary peritoneal cancer or who completed treatment less than six weeks ago

Patients with a life expectancy of less than one year

Patients with Body Mass Index (BMI) < 20 kg/m^2

Vegan vegetarians

Patients enrolled in a weight loss program or who are taking weight loss medications or dietary supplements and are unwilling to discontinue

Patients who have participated in a marathon, triathlon, or other endurance-related physical activity within the previous 24 months

Patients who have had surgery for weight loss

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719303